Nanotechnology: an integrated product policy approach

Rosalind MalcolmProfessor of LawSchool of LawUniversity of SurreyUK

The problem of definition

• Defining nanotechnology

• Determining the risk

• Designing the regulation

Risk based liability

‘to stimulate awareness of the risks and encourage the joint participation of workers and management in efforts to eliminate them’

(Health and Safety Executive, UK)

Risk and law

But………

• Where risk certain then prescriptive action

And

• The problem of self-regulation

Risk: prevention and precaution

• Known risk?

Preventive principle

• Uncertain risk?

Precautionary principle

The EU on the environment

EC Treaty, Article 174(2)

Community policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Community. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.

The EU on consumer protection

EC Treaty, Article 129a,

1. The Community shall contribute to the attainment of a high level of consumer protection through: ………

• (b) specific action which supports and supplements the policy pursued by the Member States to protect the health, safety and economic interests of consumers and to provide adequate information to consumers.

What about the precautionary principle?

Proportionality

Requires

cost-benefit-analysis /

risk assessment /

balance free trade with

environmental integration

A precautionary tale

Case T-13/99

Pfizer Animal Health SA/NV v Council (2002)

Assessing risk and nanomaterials?

When risk assessment is the basis for legislation how does it apply to nano

products?

Relevance of the precautionary principle

A nanotechnology law?

Or

Law for nanotechnology?

Current regulatory frameworks

• Health and safety law (working with nano – the workers)

• Operators’ licences (working with nano – the environment)

• Product safety regulation (using nano – the consumer)

• Waste management law (disposing of nano)

An integrated product approach

The lifecycle of a nanoproduct

Cradle to grave

Or

Cradle and grave?

Target pointsfor vertical laws

• The laboratory

• The factory

• The shop

• The home / office

• The landfill site

The vertical approach

• Research and development

• Manufacture

• Retail

• Use phase

• Disposal phase

• Transport

Regulatory gaps

• Are there gaps?

• Is new regulation required?

• What are the risks?

• Why do we need a law(s) for nanotechnology?

Identifying the gaps

• Scientific knowledge

• New legislation or adapt existing legislation?

• New codes/guidance?

• New international standards?

• Ethics? (Remember GMOs)

Regulatory challenges

Preserve and promote benefits

Protect from harm

Using an integrated product policy

• Identify risks

• Consider life cycle– Cradle to grave

• Take horizontal approach to product regulation

Integrated product policy

• Preventive (precautionary) approach

• Sustainability impact assessment

(Green Paper on Integrated Product Policy (COM(2001) 68 final) and

Communication on integrated product policy: building on environmental life-cycle thinking (COM(2003) 302 final).

Integrated product policy

3 models:

• REACH

• Environmental Impact Assessment (EIA)

• Product safety

Models for IPP

REACH (Regulation 1907/2006)

‘May not manufacture, place on market, use substances which adversely affect human health or the environment’

Models for IPP

Environmental impact assessment (EC Directive 85/337)

Whereas development consent for public and private projects which are likely to have significant effects on the environment should be granted only after prior assessment of the likely significant environmental effects of these projects has been carried out

Models for IPP

Product safety

(General Product Safety EC Directive 2001/95)

Risk assessment basis for product legislation

Reflective approach

• IPP is a procedure

• Lack of substantive challenge

But …

• Procedures are reflective, self-educational

IPP for nanotechnology?

• Nanoproducts?

• Nanoprocesses?

• EIA for nanoproducts?

Conclusions

A horizontal approach to the assessment of the impacts of nanoproducts and processes on

humans and the environment

led by science

– except where the precautionary principle applies?